Evaluation and Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients Entering Intensive Care Units for Septic Shock
Overview
- Phase
- Not Applicable
- Intervention
- Routine biological analyses
- Conditions
- Shock, Septic
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Enrollment
- 780
- Locations
- 7
- Primary Endpoint
- Negative predictive value of the studied prognostic score
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
A prognostic score was proposed by the investigative team to predict death at 1 month. This score is based on certain biological markers, scored under emergency conditions in the first 24 hours of routine clinical practice management for septic shock.
The main objective of this multicenter study is to validate the performance of the score in terms of area under the ROC curve and negative predictive value.
Detailed Description
There are two secondary objectives: * Validate a prognostic score for death at the end of the first week from initial data. * Validate a predictive score of disseminated intravascular coagulation (DIC) in patients with septic shock by comparing with the Gold Standard of the International Society on Thrombosis and Haemostasis (overt-DIC in the first 5 days after inclusion). As for the main objective, these scores are based on biological markers scored under emergency situations within the first 24 hours of routine clinical practice management for septic shock. The objectives and endpoints stated correspond to the protocol directly submitted to ethics authorities prior to the first inclusion and can be verified by contacting the Committee for the Protection of Persons Sud Mediterranée III (mail: CPP SUD-MEDITERRANEE III, UFR MEDECINE 186, chemin du Carreau de Lanes CS 83021, 30908 NIMES Cedex 2 FRANCE. Study reference: 2008.11.04 bis) For more information: carey.suehs@chu-nimes.fr
Investigators
Eligibility Criteria
Inclusion Criteria
- •patient (or representative) received the information notice
- •patient has hemodynamic insufficiency of non-traumatic or cardiogenic origin associated with severe sepsis (treated with Noradrenalin) and organ dysfunction, hypoperfusion or hypotension
- •body temperature \> 38.3°C or \< 36°C
- •heart rate \> 90 bpm
- •Tachypnea \> 20 C/min or PaCO2 \< 32 mmHg or mechanical ventilation
- •leukocytes \> 12000 µL-1 ou \< 4000 µL-1 ou \> 10% immature forms
- •oliguria \< 0.5 ml/kg/h for at least 2 hours
- •abrupt alteration (24 h) of conscienceness
- •thrombocytopenia \< 100 000 G/L or disseminated intravascular coagulation
- •mottled skin and / or capillary refill time\> 3 sec
Exclusion Criteria
- •patient is dying or limitation or cessation of active treatment
- •patient is already included in another trial
- •patient or family refusal
- •patient not affiliated with a social security system
Arms & Interventions
Septic shock patients
Intervention: Routine biological analyses
Outcomes
Primary Outcomes
Negative predictive value of the studied prognostic score
Time Frame: 24 hours (studied score parameters); 1 month (mortality)
The biological parameters measured at the time of admission to the intensive care unit and that make up the prognostic score for death at 1 month will be collected. The event "death within 1 month" will be analyzed. For patients discharged from service before the end of the first month, the clinician will still be informed concerning possible death. The studied biological parameters correspond to routine coagulation and hematological parameters for patients in septic shock, according to SFAR (Société Française d'Anesthésie et de Réanimation) recommendations and the SRLF (Société de Réanimation de Langue Française) Consensus (2002).
AUC of the studied prognostic score
Time Frame: 24 hours (studied score parameters); 1 month (mortality)
The biological parameters measured at the time of admission to the intensive care unit and that make up the prognostic score for death at 1 month will be collected. The event "death within 1 month" will be analyzed. For patients discharged from service before the end of the first month, the clinician will still be informed concerning possible death. The studied biological parameters correspond to routine coagulation and hematological parameters for patients in septic shock, according to SFAR (Société Française d'Anesthésie et de Réanimation) recommendations and the SRLF (Société de Réanimation de Langue Française) Consensus (2002).
Secondary Outcomes
- Negative predictive value for the studied prognostic score(24 hours (studied score parameters); 5 days (DIC))
- AUC of the studied prognostic score(24 hours (studied score parameters); 5 days (DIC))
- Negative predictive value of the studied prognostic score(24 hours (studied score parameters); 1 week (mortality))